MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

Event Description

It did not control the bleeding [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from a physician via company representative, referring to a female patient of unknown age.The patient's medical history included pregnancy and previous caesarean section.For her latest singleton pregnancy, she was not induced and was not dilating so was sent for an emergent caesarean.Her current conditions included uterine atony and multigravida (reported as baby number 5).The patient lost 2 liters of blood prior to vacuum-induced hemorrhage control system (jada system) placement and remained in the operating room (considered as hospitalization).Her concomitant medications included methylergometrine maleate (methergine), carboprost trometamol (hemabate) and oxytocin (pitocin).Her past drugs and allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route (lot#, serial# and expiry date were not reported) by the attending physician for postpartum hemorrhage.Reportedly, the device came with a blue seal valve.It was reported that the vacuum-induced hemorrhage control system (jada system) was not in place but for a few minutes (also reported as "a couple of minutes"), and it did not control the bleeding (device ineffective, onset date: on (b)(6) 2023) and on the same day, the vacuum-induced hemorrhage control system (jada system) was removed.The patient sought medical attention and the physician opted to perform a hysterectomy.There was a 4.5 liters of total blood loss, however, the physician could not perform any transfusion as patient was a jehovah's witness.Reportedly, the maternal admission in the intensive care unit (icu) was required, and the patient was still in the icu at the time of reporting (considered as hospitalization prolonged).On (b)(6) 2023, the patient's hemoglobin and hematocrit (reported as "h/h") were 5.5 and 17 (units not reported), and her platelets were 65 (units not reported).There was no invasive placenta, and the patient was not diagnosed with endometritis or disseminated intravascular coagulation.The suspected cause of the postpartum hemorrhage was uterine atony.No additional adverse event (ae), and no product quality complaint (pqc) was reported.It was unknown if vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was considered to be serious as it required intervention.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 17049121
• MDR Text Key: 316392422
• Report Number: 3002806821-2023-00067
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMABATE (CARBOPROST TROMETAMOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; PITOCIN [OXYTOCIN] (OXYTOCIN),
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female